MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482804650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	02/09/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was required to replace the rod that migrated.
Additional Manufacturer Narrative
Method: no methods performed.Concomitant product.Results: no results available because no method was performed.Concomitant product.Conclusion: no product issue related to the reported event was found with this product, so this is a concomitant product.Related adverse event reported under 0009617544-2016-00094.
Event or Problem Description
It was reported that a revision surgery was required to replace the rod that migrated.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE L 6.5X50MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5480363
• Report Number: 0009617544-2016-00091
• Device Sequence Number: 10837705
• Product Code: NKB
• UDI-Device Identifier: 07613327002195
• UDI-Public: 07613327002195
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 482804650
• Device Lot Number: 157917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2016
• Supplement Report FDA Received Date: 05/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR